Suture anchor and associated methods of use

ABSTRACT

A method for securing a sleeve in a bore hole in bone. The method includes disposing at least a portion of a length of filament into the bore hole, and implanting the sleeve into the bore hole such that a first pathway extending through first and second ends of the sleeve opens in a direction toward the opening of the bore hole and in a direction toward the base of the bore hole. The method also includes pulling at least a portion of the length of filament through the first pathway of the sleeve, thereby forming a first loop configuration extending from the first end and at least one free end of the length of filament extending from the second end. Also included is passing the at least one free end through the first loop configuration to create a one-way cinch.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/525,636, filed on Oct. 28, 2014, the disclosure of which isincorporated by reference.

BACKGROUND OF THE INVENTION

Soft tissue structures, such as fibrocartilage, ligaments and tendons,facilitate connections between multiple anatomic components. Injuriescan partially and/or completely sever such structures leading toimmobility and/or dysfunction of the anatomic components. In oneexample, a shoulder injury may tear a portion of the rotator cuff fromits connection to bone, leading to instability of the shoulder joint andcausing the naturally tensioned tendon to slacken. In another example, ashoulder injury may separate a portion of the glenoid labrum from theunderlying bony structure leading to joint instability.

In some instances surgery may be needed to repair or replace the damagedsoft tissue, which often involves anchoring the tissue in its naturalposition until fully healed. Traditionally, this was achieved bytethering the damaged tissue with a filament to a metal or hardenedpolymer anchoring device fixed to a bony structure. However, in manyinstances, such traditional anchoring devices tend to be large indiameter, and must include sufficient material, or other additionalstructures, to withstand pullout forces. The size of such devices maylimit implantation locations in the body, as sufficient bone mass isrequired to accommodate the device.

Recent trends in tissue anchoring have seen the emergence of “soft”devices, also referred to as “filamentary” fixation devices, in whichthe anchoring device itself may be constructed of filamentary material,such as suture or the like. Despite the many benefits these filamentaryfixation devices provide, such devices, to date, cannot be used toperform knotless surgical procedures, that is, surgical procedures usingfilaments (such as sutures or the like) where the filament is securedwithout the need of tying knots, such as half hitches or the like.Further, such devices, while generally capable of being anchored in asmaller bone hole than traditional anchoring devices, may still requirea hole too large for certain applications.

BRIEF SUMMARY OF THE INVENTION

Generally, the present disclosure relates to devices, systems, methodsand kits for knotless tissue anchoring applications, and in particular,to knotless tissue anchoring applications utilizing a device anchoredwithin a minimal bone hole.

In one aspect of the present disclosure, a method for securing a sleevein a bore hole in bone, the bore hole having an opening, a base and awall extending between the base and opening. The method includesdisposing at least a portion of a length of filament into the bore hole,and implanting the sleeve into the bore hole such that a first pathwayextending through first and second ends of the sleeve opens in adirection toward the opening of the bore hole and in a direction towardthe base of the bore hole. The method also includes pulling at least aportion of the length of filament through the first pathway of thesleeve, thereby forming a first loop configuration extending from thefirst end and at least one free end of the length of filament extendingfrom the second end. Further included in the method is passing the atleast one free end through the first loop configuration to create aone-way cinch.

In addition, the length of filament may be adapted to apply tension to atissue in working relationship with the length of filament. The sleevemay be made of filamentary material. Further, the sleeve may include asidewall and a plurality of fenestrations extending through the sidewallinto the first pathway. When the sleeve is implanted in the bore hole,each of the plurality of fenestrations may be disposed adjacent to andopen towards the wall of the bore hole.

Further, the method may also include engaging the length of filamentwith an inserter device prior to the disposing step, and disengaging theinserter device from the length of filament after the pulling step. Theinserter device may include a filament engagement element for engagingand retaining the length of filament, and disengaging the inserterdevice from the first loop configuration may include moving the filamentengagement element from a first position to a second position to releasethe single length of filament.

Continuing with this aspect, the method may include tensioning the atleast one free end such that the first loop configuration, with the atleast one free end positioned therethrough, travels toward and into thefirst pathway of the sleeve. Further, the method may include, prior tothe pulling step, pulling the at least one free end and the at least aportion of the length of filament into and through a second pathway inthe sleeve from the first end of the sleeve, and maneuvering the atleast one free end and the at least a portion of the length of filamentaround a boundary separating the first and second pathways. The boundarymay be a tab formed from a portion of the sleeve. Also, the first andsecond pathways may intersect at at least one location along the lengthof the sleeve.

In another aspect of the present disclosure, a method for securing asleeve in a bore hole in bone, the bore hole having a base, an opening,and a wall disposed between the base and opening. The method includesimplanting the sleeve into the bore hole. The sleeve has a lengthdefined between a first end and a second end and a first pathwayextending along the length of the sleeve. The method also includespassing at least a portion of a length of filament through the firstpathway from the second end through the first end such that the at leasta portion of the length of filament forms a first loop configurationthat extends from the first pathway at the first end and at least onefree segment of the length of filament having a free end that extendsfrom the second end. Additionally, the method includes passing the freeend of the at least one free segment through the first loopconfiguration such that the first loop configuration, with the free endpositioned therethrough, forms a one-way cinch.

In addition, the first loop configuration and the first end of thesleeve may trap the at least first free segment to form the one-waycinch. The method may also include, prior to the passing steps, engagingthe at least a portion of the length of filament with an inserterdevice. Further, the method may include disengaging the inserter devicefrom the length of filament after the step of passing the at least aportion of the length of filament through the first pathway to form thefirst loop configuration. Disengaging the inserter device from the firstloop configuration may include actuating a filament engagement elementto release the length of filament.

Continuing with this aspect, the sleeve may include an outer surface anda plurality of openings extending from the outer surface into the firstpathway. When the sleeve is implanted in the bore hole, each of theplurality of openings may be disposed adjacent to and open towards thewall of the bore hole. The sleeve may also include a second pathwayjuxtaposed with the first pathway. Prior to passing the at least aportion of the length of filament through the first pathway, the methodmay include passing the free end and the at least a portion of thelength of filament through the second pathway from the first end of thesleeve through the second end of the sleeve. The first and secondpathways may intersect at at least one location along the length of thesleeve. The sleeve may be made of filamentary material.

In a further aspect of the present disclosure, a method for securing asleeve in a bore hole in bone, the bore hole having a base, an opening,and a wall disposed between the base and opening. The method includesimplanting the sleeve into the bore hole such that a first end of thesleeve is disposed adjacent the opening of the bore hole and a secondend of the sleeve is disposed adjacent the base of the bore hole, suchthat in this position the sleeve stands in a vertical configurationwithin the bore hole. The method may also include passing a portion offilament into and along a first pathway of the sleeve, maneuvering theportion of filament around a boundary between the first pathway and asecond pathway of the sleeve, forming a first loop configurationextending from the first end of the sleeve, passing the portion offilament through the first loop configuration forming a second loopconfiguration, and tensioning the portion of filament such that thefirst loop configuration is pulled towards the first end of the sleeve.

In yet another aspect of the present disclosure, a method for securing asleeve in a bore hole in bone, the bore hole having a base, an opening,and a wall disposed between the base and opening. The method includesimplanting a sleeve into the bore hole such that a first end of thesleeve is disposed adjacent the opening of the bore hole and a secondend of the sleeve is disposed adjacent the base of the bore hole, suchthat in this position the sleeve stands in a vertical configurationwithin the bore hole. The method also includes passing a portion offilament into and through a first pathway of the sleeve such that theportion of filament forms a first loop configuration extending from thefirst pathway in a first direction and at least one filament freesegment extends from the first pathway in a second direction. The atleast one filament free segment has a free end. The method furtherincludes passing the at least one free end of the length of filamentthrough the first loop configuration, and tensioning the at least onefree end such that the first loop configuration is pulled toward thefirst end of the sleeve and the first loop configuration and sleevetraps the at least one filament free segment.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1A illustrates one embodiment of an inserter device.

FIG. 1B illustrates one embodiment of an anchoring sleeve in a firstcondition.

FIG. 1C illustrates the anchoring sleeve of FIG. 1B in a secondcondition.

FIG. 1D illustrates the anchoring sleeve of FIG. 1B in an alternativesecond condition.

FIG. 2 illustrates a step of one embodiment of a method of use of theinserter and anchoring sleeve of FIGS. 1A and 1B or a method of assemblyof an anchoring assembly.

FIG. 3 illustrates another step of the method embodiment of FIG. 2.

FIG. 4 illustrates an additional step of the method embodiment of FIGS.2 and 3.

FIG. 5 illustrates a further step of the method embodiment of FIGS. 2-4.

FIG. 6 illustrates yet another step of the method embodiment of FIGS.2-5.

FIG. 7 illustrates a still further step of the method embodiment ofFIGS. 2-6.

FIG. 8 illustrates an alternative method of use or assembly.

FIG. 9 illustrates another embodiment of an anchoring sleeve and analternative method of use or assembly.

FIGS. 10-12 illustrate another embodiment of an inserter device andmethod of use or assembly.

DETAILED DESCRIPTION

The anchoring devices, assemblies, systems, and associated methods ofuse of the present invention are intended for use in the repair,reattachment, replacement or otherwise securement of tissue, includingboth hard tissue (i.e., bone or the like) and soft tissue. Soft tissuemay be, for example, meniscus, cartilage, capsule, ligaments andtendons, replacement grafts of any of these soft tissues, or the like.While many of the exemplary methods disclosed herein are directedtowards the use of fixation assemblies and systems involving ananchoring sleeve for implantation into a bone hole, other uses, some ofwhich are described herein, are also envisioned. Additionally, thedevices, assemblies, systems and methods disclosed herein arecontemplated for use in both open surgery and arthroscopic surgery.

As used herein, “proximal” or “proximally” means closer to or towards anoperator, e.g., surgeon, while “distal” or “distally” means further fromor away from the operator. Also, as used herein, the terms “about,”“generally” and “substantially” are intended to mean that slightdeviations from absolute are included within the scope of the term somodified.

As used herein, the term “filament” or “filamentary” is defined as asuture or other thread-like material. Such filaments may be constructedof synthetic material (e.g., PLGA, UHMWPE (ultra high molecular weightpolyethylene), polyester, PEEK, Nylon, polypropylene, aramids (forexample Kevlar®-based fibers) or the like, or blends thereof), organicmaterial (silk, animal tendon, or the like or blends thereof), or blendsof both one or more organic materials and one or more syntheticmaterials. Alternatively, filaments may include thin metal wires. Whileany of these materials may be used, it is preferable, and is disclosedherein, that the various filaments or filamentary aspects of the presentinvention be constructed out of suture, such as UHMWPE, polyester orblends thereof.

The present invention relates to the use of suture anchors to securesuch filaments in the anatomy, commonly a bore hole formed in bone. Asused herein, “suture anchor” can be any structure suitable for securinga filament to bone. In one embodiment, the suture anchor is an anchoringsleeve or sleeve, and preferably, the anchoring sleeve or sleeve isformed of a filamentary material.

FIGS. 1A-1D depict one embodiment of an anchoring sleeve 20 and aninserter device 10 for inserting sleeve 20 into a bore hole in bone.Sleeve 20 may be made from filamentary material and is generallycylindrical in shape and includes a longitudinal axis defined between afirst end 22 and second end 24. The sleeve 20 has an aperture 26extending through the length of sleeve 20 from the first end 22 to thesecond end 24, forming a pathway therethrough, and several slits 27formed in a sidewall 25 of the sleeve 20 in a direction transverse tothe longitudinal axis. A pair of slits 27 forms a tab 28 out of thesidewall, which is moveable from a position of alignment with theremainder of the sidewall into a position located within aperture 26.When a tab 28 is positioned within the aperture 26, a fenestration 29 isformed in the sidewall 25 of sleeve 20. Sleeve 20 can have a pair ofslits 27 forming one tab 28, or multiple pairs of slits 27 forming twoor more tabs 28, and, therefore, two or more fenestrations 29,respectively.

The respective lengths of a pair of slits 27 helps determine the lengthof each corresponding tab 28, which in turn helps determine how farwithin the aperture 26 each tab can be located from its initial positionaligned with the sidewall, as shown in FIG. 1B. For example, asillustrated, the length of each slit 27 within a pair may besubstantially half of the circumference of sleeve 20. In such aconfiguration, a tab 28 formed by such slits 27 is capable of beingpushed into or otherwise positioned into the aperture 26 so that theentire inner surface of the tab 28 can be placed into contact or flushwith the entire inner surface of sleeve 20 that is disposed opposite theinner surface of tab 28 (best shown in FIG. 1C). Moreover, in suchembodiment, the inner surface of the tab 28 forms an arc having a radiussubstantially the same as the inner radius of sleeve 20 such that theaperture 26 remains free of obstacles. In an alternative, the tabs 28may simply be cut and excised from the sleeve, if desired.

The aperture 26 may form a single pathway or be segmented into multiplepathways. As used herein, the term pathway means a route of travel thatis defined by a boundary, such as the sleeve sidewall 25 and/or a tab 28for an item or object, such as a filament, to pass into and/or throughthe aperture 26. In the embodiment described above in which respectiveslits 27 have a length substantially half of the circumference of sleeve20, the aperture 26 may form a single pathway where the tab 28 is eitheraligned with the sidewall (FIG. 1B) or where the inner surface of thetab 28 fully contacts the inner surface of sleeve 20 opposite the tab 28(FIG. 1C). In one example where this tab 28 is not pushed or otherwisepositioned within the aperture 26 to its full extent, the tab 28 mayseparate the aperture 26 into a first pathway 21 and a second pathway23, as best shown in FIG. 1D. In another example, the sidewall 25 itselfmay provide a boundary separating the aperture 26 into multiplepathways, where, for instance, the sidewall 25 includes fenestrations29. In such an example, the sidewall 25 between adjacent fenestrations28 can be inverted and positioned, similar to tab 28, within theaperture 26 to form a boundary separating the aperture 26 into multiplepathways.

In other embodiments, the respective lengths of a pair of slits 27 maybe less than half of the circumference of the sleeve 20. In such anembodiment, when a tab 28 formed by such slits 27 is moved to its fullextent into the aperture 26, the inner surface of the tab 28 forms anarc having a radius less than the inner radius of sleeve 20. As such, atleast a portion of the tab 28 is disposed within the space formed bysleeve 20 without contacting the inner surface of sleeve 20 opposite theinner surface of tab 28, which separates the aperture into at least twopathways (also depicted by FIG. 1D). While it is possible that therespective lengths of a pair of slits 27 can be greater than half of thecircumference of the sleeve 20, such lengths are preferablysubstantially half the length of the circumference or less.

In other embodiments, the sleeve 20 may not have any tabs 28, but rathermay have at least one fenestration 29 formed in the sidewall 25. Anexemplary anchoring sleeve of this type is the Iconix® line offilamentary fixation products (Stryker Corporation, Kalamazoo, Mich.).Other configurations are also envisioned, examples of which aredisclosed in U.S. application Ser. Nos. 13/783,804, filed Mar. 4, 2013;13/303,849, filed Nov. 23, 2011; 13/588,586, filed Aug. 17, 2012;13/588,592, filed Aug/ 17, 2012; and U.S. Pat. Nos. 5,989,252 and6,511,498, the entireties of which are incorporated by reference hereinas if fully set forth herein and all of which are assigned to the sameentity as the present invention. In these embodiments, the aperture 26of the sleeve 20 may form a single pathway. However, the sidewall 25itself may provide a boundary separating the aperture into multiplepathways, where, for instance, the sidewall includes multiplefenestrations 29. In such an example, the fenestrations allow a portionof the sidewall disposed between each fenestration to depress inwardlyto form a boundary separating the aperture 26 into multiple pathways.

The inserter 10 generally includes an outer sheath 12 and inner member14. The outer sheath 12 may be cylindrical and cannulated so that theinner member 14, which may also be cylindrical, is slidingly receivedwithin the outer sheath 12. As such, the outer diameter of the outersheath 12 is larger than the outer diameter of the inner member 14,which forms a shoulder 13 between the outer sheath 12 and inner member14. The thickness of a sidewall of the outer sheath 12 may besubstantially the same thickness as that of the sidewall 25 of thesleeve 20 such that when sleeve 20 is loaded onto inner member 14, theouter surfaces of sleeve 20 are substantially tangent to the outersurfaces of outer sheath 12.

In some embodiments, the inner member 14 may have a groove extendingalong its length that is complementary to a tongue extending along thelength of the inner surface of the outer sheath 12. Such a tongue andgroove interface (not shown) can facilitate longitudinal translation ofthe inner member 14 relative to the outer sheath 12, while prohibitingrelative rotational movement. In other embodiments, longitudinaltranslation and rotational restraint may be provided by a pin and slotinterface. In further embodiments, a spring may bias against the innermember 14 extending from a distal end of the outer sheath 12, which mayhelp prevent incidental relative translational movement between theinner member 14 and outer sheath 14 and also provide operator feedbackduring use.

The inner member 14 includes an actuating member 15 extending from adistal end. As illustrated in FIGS. 1A and 2-4, the actuating member 15may be a pair of moveable arms 17, 18 that are moveable from a firstposition to a second position. In the first position, the arms 17, 18,which may be curved, may clamp together at a distal end of each arm. Thecurvature of the arms 17, 18 forms an opening 16 between the arms toallow for the passage and containment of a filament, such as a suture(as in FIG. 2, for example). In the second position, as in FIG. 4 forexample, the distal end of each arm 17, 18 may be separated by a gap soas to allow a filament disposed within the opening 16 to be releasedwithout having to unthread the filament from opening 16. Such actuationmay be performed by an operator at the proximal end of the inserterdevice 10, such as by a lever mechanism (not shown) or the like, whichmay be particularly useful during an arthroscopic procedure,particularly where both ends of the filament are being used, areconnected to other objects, or the like. Of course, if a surgicalprocedure allows one end of the filament to remain free, the arms 17, 18need not be actuatable.

FIGS. 2-7 depict one embodiment of a method of use of inserter 10 andsleeve 20, or, alternatively, a method of assembly of an anchoringassembly comprising a working filament 30 and anchoring sleeve 20.Referring to FIG. 2, sleeve 20 may be loaded onto the inserter 10. Thismay be done during the manufacturing process and delivered to theoperating room in a preloaded configuration, or, alternatively, sleeve20 may be loaded onto inserter 10 in the operating room during or justprior to the procedure. Generally, sleeve 20 is loaded onto inserter 10by pushing or otherwise placing the tabs 28 into the aperture 26,preferably to their full extent, and then sliding the sleeve 20 over theinner member 14 such that inner member 14 is disposed within aperture 26or pathway. In some embodiments, the tabs 28 may remain in their initialposition aligned with the sidewall 25 as sleeve 20 is slid over theinner member 14. The first end 22 of sleeve 20 preferably contacts theshoulder 13.

Continuing with the discussion of the illustrated embodiment of a methodof securing an anchoring sleeve, and filament, in a bore hole, as inFIG. 2, a working filament 30 may be passed through or around a targettissue 40, which may result in first and second free ends 32, 34 of theworking filament 30 extending from the target tissue 40, or only asingle free end depending on the technique utilized for ensnaring tissue40, as is known in the art. Where two free ends 32, 24 result from theensnarement of tissue 40, the free ends may be passed into the opening16 between arms 17 and 18 either by threading the free ends 32, 34through the opening 16 or by grabbing the free ends 32, 34 by actuatingthe arms 17, 18 from the second to the first position. This may beperformed either in vivo or external to the patient. Of course, incertain instances, the filament need not be passed through the tissueprior to being positioned through the opening, though in practice,positioning the filament through tissue first would be standard.

Thereafter, the distal end of the inserter 10, with the sleeve 20 and atleast a portion of the working suture 30 loaded thereto, is insertedinto a bore hole 40 previously formed in bone, as best shown in FIG. 3.Slight tension is preferably applied to the free ends 32, 34 duringinsertion to help ensure that the working filament 30 does not becometangled or bunched within the bore hole 42. The inserter 10 iscontinuously pushed into bore hole 42 until the sleeve 20 is completelydisposed therein and, preferably, at least a portion of the outer sheath12 is also disposed within the bore hole 12 to ensure placement of thesleeve 20 within bone. The outer diameter of the sleeve 20 is sized withrespect to the diameter of the bore hole 42 to provide a tight fitwithin the bore hole 42 when inserted. When fully inserted, the sleeve20 stands upright such that the second end 24 of sleeve 20 is adjacentthe base 46 of the bore hole 42 and the first end 22 of sleeve 20 isadjacent the opening 44 of the bore hole 42. As in FIG. 4, a portion ofthe working filament 30 may be disposed between the second end 24 ofsleeve 20 and the base 46 of the bore hole 42.

Once fully inserted into the bore hole 42, the inner member 14 may beretracted within the outer sheath 12 while the outer sheath 12 remainsin substantially the same position. As the inner member 14 is retracted,the outer sheath 12 prevents the sleeve 20 from being displaced from thebore hole 42 by the retraction of the inner member 14. Additionally, thefriction applied to the inner surfaces of sleeve 20 by the inner member14 may cause sleeve 20 to buckle or collapse in a longitudinaldirection, which, in turn, may cause the outer surface of sleeve 20 toexpand outwardly and firmly press against the inner surface of the borehole 42. It is noted that the corresponding dimensions between the outersheath 12 and sleeve 20 allow the distal end of the outer sheath 12 toat least partially enter into the bore hole 42 while prohibiting thesleeve 20 from being incidentally removed from the bore hole 42 as innermember 14 is retracted.

As the inner member 14 is retracted within the outer sheath 12, theactuating member 15 pulls at least a portion of the working filament 30into and through the aperture 26 to form a first loop configuration 36extending from the first end 22 of sleeve 20. Once, the inner member 14is fully retracted within the outer sheath 12, the distal end of theouter sheath 12 may be removed from the bore hole 42 and the moveablearms 17, 18 actuated to the second position so that the first loopconfiguration 36 is released from the actuating member 15, as best seenin FIG. 4. At this point, the routing of the working filament 30 is assuch: the working filament 30 extends from the tissue 40 and entersthrough the opening 44 of the bore hole 26; runs along the outer surfaceof sleeve 20 towards the base 46 of the hole 42; enters into the secondend 24 of sleeve 20 adjacent the base 46 of bore hole 42; extendsthrough the aperture and exits and then reenters the aperture 26 at thefirst end 22 of sleeve 20 to form the first loop configuration 36; exitsthe second end 22 of sleeve 20; and runs along the outer surface ofsleeve 20 toward the bore hole opening 44, terminating at the first andsecond free ends 32, 34 exiting from the bore hole 42.

With the free ends 32, 34 extending from the bore hole 42, the free ends32, 34 are passed through the first loop configuration 36 to form asecond loop configuration 38 formed between the first and second ends22, 24 of sleeve 20. It is noted that when the first loop configuration36 is first formed by the inserter 10, the first loop configuration 36may be pulled through an arthroscopic cannula where the operatorreleases the first loop configuration 36 from the inserter 10 formanipulation by the operator outside of the patient. Such manipulationmay include forming the second loop configuration 38 with the free ends32, 34 outside of the patient.

Once the free ends 32, 34 are passed through the first loopconfiguration 36, the free ends are tensioned, as shown in FIGS. 5 and6. As tension is applied to the free ends 32, 34, the first loopconfiguration 36 contracts and moves towards the aperture 26 of sleeve20 and the portion of the working filament 30 disposed between thetissue 40 and bore hole 42 tensions the tissue 40, and in someapplications, draws tissue 40 closer to the bore hole 42. As tension iscontinuously applied to free ends 32 and 34, the first loopconfiguration 36 constricts the portion of the working filament 30passing therethrough, the second loop configuration 38 cinches down andconstricts sleeve 20. The friction applied to the working filament 30and sleeve 20 caused by the constriction of these loop configurations36, 38 creates a one-way cinch/one-way locking cleat (best shown in FIG.6) that allows the working filament 30 to slide toward the operatorthrough the first loop configuration 36, but prevents the slackening ofthe working filament 30 between the first loop configuration 36 andtissue 40 when the operator removes tension from the free ends 32, 34.Additionally, the constriction of the sleeve 20 by the second loopconfiguration 38 may axially compress the sleeve 20, which, in turn,helps further expand the outer surfaces of sleeve 20 against innersurface of the bore hole 42, which facilitates firm anchoring of thesleeve 20 to bone, thereby increasing pullout strength. Once the tissue40 and one-way cinch is sufficiently tensioned, the operator may cut thefree ends 32, 34, as illustrated in FIG. 7. While no knots are requiredto maintain this repair, the surgeon may create one or more knotsutilizing the free ends of the filament, as known in the art.

FIG. 8 depicts an alternative routing embodiment of working filament 130with respect to anchoring sleeve 120. As discussed above, anchoringsleeve 120 is depicted as having two pairs of slits 127 forming two tabs128 a, 128 b which do not invert to lie flush against the inner sidewallof the sleeve 120. Anchoring sleeve 120 can have more or less tabs thanshown, and is similar to anchoring sleeve 20. Generally, with the sleeve120 disposed within a bore hole 142 in the orientation previouslydescribed, free ends 132, 134 extend from the target tissue 140 andenter through the first end 122 of sleeve 120 into a first pathway 150defined within the aperture by the tabs 128 a, 128 b and inner sidewallof sleeve 120. The free ends 132, 134 extend through the first pathway150 in a first direction toward the second end of sleeve 120 and thebase 146 of the bore hole 142. The free ends 132, 134 curve around thesecond tab 128 b and extend through a second pathway 152 defined withinaperture 126 also by the tabs 128 a, 128 b and inner sidewall in asecond direction toward the first end 122. Free ends 132, 134 extendfrom and reenter the first end 122 of sleeve 120 into the second pathway152 to form a first loop configuration 136 similar to first loopconfiguration 36. First and second ends 132, 134 then pass back throughthe second pathway 152 and extend out of the second end of sleeve 120where the first and second free ends 132, 134 travel along the outsideof sleeve 120 toward the opening of the bore hole 142 where the freeends 132, 134 exit through the bore hole 142. The free ends 132, 134pass through the first loop configuration 136 to form a second loopconfiguration 138 much like second loop configuration 38.

This routing configuration is similar to the routing configurationpreviously described with respect to sleeve 20 but differs in thatworking filament 130 is first routed through the first pathway 150within the aperture 126 rather than along the outer surface of thesleeve. Such routing is facilitated by the tabs 128 a, 128 b beingdisposed within aperture 126 to help define the first and secondpathways 150, 152.

In an alternative method of use of inserter 10 and/or method of assemblyof an anchoring assembly that includes sleeve 120 and working filament130, working filament 130 is retrieved after ensnaring the target tissue140 and passed through the first pathway 150 of sleeve 120 from thefirst end 122 toward the second end 124 of sleeve 120. The passage ofthe working filament 130 through the first pathway 150 is preferablyperformed during the procedure and preferably outside of the patientwhere the procedure is performed arthroscopically. With the free ends132, 134 extending through the first pathway 150, the sleeve 120 isloaded onto the inner member 14, which is sized to be positioned throughthe second pathway 152 such that the first end 122 of sleeve 120 abutsouter sheath 12.

Once sleeve 120 is loaded onto the inner member 14 of inserter 10, theworking filament 130 extending from the second end 124 of sleeve 120 iseither threaded through the opening 16 between the moveable arms 17, 18or grabbed by the actuation of the arms 17, 18 from the second to thefirst position. Thereafter, sleeve 120 is inserted into the bore hole142 and the inner member 14 is retracted through the first pathway 150in a similar fashion as previously described to form the first loopconfiguration 136. The working ends 132, 134 are passed through thefirst loop configuration 136 to form the second loop configuration 138and one-way cinch, as shown in FIG. 8.

FIG. 9 depicts another of the many possible sleeve embodiments andworking suture routings. Sleeve 220 includes six fenestrations 229 a-f,although sleeve 220 could include more or less fenestrations. Thesefenestrations 229 a-f extend through the sidewall 225 of sleeve 220 intoan aperture 226 formed therein. Generally, a first group of threefenestrations 229 a-c are aligned along the length of the sleeve 220,and another group of three fenestrations 229 d-f are aligned along thelength of the sleeve in an opposite location from the first group offenestrations 229 a-229 c. It is noted that this is merely an example,as sleeve 220 can have a group of two or more fenestrations in variouslocations around the circumference of sleeve 220. It is also noted thatthe fenestrations 229 a-f in this embodiment are not formed by thepositioning of a tab within the aperture 226, rather fenestrations 229a-f may be gaps within the braiding of the sleeve 220 or holes ofvarious shapes formed in the sidewall 225 of sleeve 220.

Generally, with sleeve 220 disposed within a bore hole 242 in bone in anupright orientation as previously described, free ends 232, 234 extendfrom the target tissue 240 and enter into the bore hole 242 between thesleeve's outer surface and bore hole's inner surface. Free ends 232, 234enter into the aperture 226 through the first fenestration 229 a and runalong the inner surface of the sleeve 220 where free ends 232, 234 passthrough the second fenestration 229 b and extend along the outer surfaceof sleeve 220. From the outer surface of sleeve 220, free ends 232, 234extend through the third fenestration 229 c where the working filament230 forms a first loop configuration 236, similar to first loopconfigurations 36 and 136, such that the first loop configuration 236extends from the first end 222 of sleeve 210. From the first loopconfiguration 236, free ends 232, 234 extend through the fourthfenestration 229 d and run along the outer surface of sleeve 220 wherethe ends pass through the fifth fenestration 229 e. The free ends 232,234 extend along the inner surface of sleeve 220 and then pass throughthe sixth fenestration 229 f where the ends run along the outer surfaceof sleeve 220 and out of the opening 244 of the bore hole and throughthe first loop configuration 236 to form a second loop configuration 238and one-way cinch, as previously described.

The sidewall 225 between the second and third fenestrations 229 b, 229 cand between the fourth and fifth fenestrations 229 d, 229 e helps toform three separate pathways 250, 252 and 254. In some embodiments, thesidewall 225 between these fenestrations 229 b-e may be narrower, thatis, has a smaller diameter, than the remainder of sleeve 220. In otherembodiments, the sidewall 225 between the second and third fenestrations29 b, 229 c and fourth and fifth fenestrations 229 d, 229 e may act liketabs, such as tabs 28 and 128, formed by these fenestrations 229b-e,wherein such tabs/sidewall can be pushed or otherwise placed within theaperture 226 or merely provide boundaries forming separate routes oftravel for the working filament 230.

In a method of use or method of assembly of an anchoring assemblycomprised of sleeve 220 and working filament 230, working filament 230is retrieved after ensnaring the target tissue 240. In arthroscopicprocedures, the first and second ends 232, 234 of the working suture 230may be withdrawn through an arthroplasty cannula for manipulation by theoperator outside the patient. The free ends 232, 234 are then routedthrough the sleeve 220 by first running the free ends 232, 234 along thefirst pathway 250 by passing the free ends 232, 234 through the firstfenestration 229 a, along the inner surface of sleeve 220, throughsecond fenestration 229 b and then through the third fenestration 229 cinto a second pathway 252. The free ends 232, 234 are then extendedacross the second pathway 252 through the fourth fenestration 229 d andinto the third pathway 254. The free ends 232, 234 are extended alongthe third pathway 254 through the fifth and sixth apertures 229 e and229 f. Generally, the working filament 230 is provided enough slack asit crosses the second pathway 252 to provide room for sleeve 220 to beloaded onto an inserter, such as inserter 10. As discussed in greaterdetail below, a loader, such as loader 360 in FIG. 10, can be used toroute the filament 230 through the various fenestrations as illustrated.The loader may be pre-positioned through the fenestration(s) 229 a-f sothat the working filament 230 can be loaded into the loader loop, andwith tension applied to the loader, pulled through the desiredfenestration(s) 229 a-f.

Thereafter, sleeve 220 may be loaded onto inserter 10 by sliding thesleeve 220 onto the inner member 14 as previously described. Theactuating member 15 may then be actuated to move the arms 17 and 18 fromthe second to the first position to grab the working filament 230adjacent the second end of sleeve 220. Sleeve 220 is then inserted intoa bore hole 242 and the inner member 14 is retracted into the outersheath 12, as previously described herein. While the inner member 14 isretracted, tension is applied to the working filament 230 by theactuating member 15, which may pull the third and fourth fenestrations229 c, 229 d closer to the second and third fenestrations 229 b, 229 e,respectively. This may cause the sleeve sidewall 225 about the sleeve'scircumference between the second and third fenestrations 229 b, 229 cand fourth and fifth fenestrations 229 d, 229 e to collapse and expandoutwardly against the inner surface of the bore hole 242 to facilitate afirm anchoring position. In some embodiments, the sleeve sidewall 225about the sleeve's circumference between the first and secondfenestrations 229 a, 229 b and between the fifth and sixth fenestrations229 e, 229 f may also collapse in this manner

Once the inner member 14 is fully retracted and the first loopconfiguration 236 is formed, the filament free ends 232, 234 may bepassed through the first loop configuration 236 to form a second loopconfiguration 238 and one-way cinch. Tension is applied to the filamentfree ends 232, 234, which locks down the one-way cinch, and may alsohelp further collapse the sidewall segments between fenestrations 229a-f to further anchor sleeve 220 in the bore hole 242.

Shifting focus of the description, alternative inserter devices andmethods of use are now described. With reference to FIGS. 1-4, in onealternative embodiment (not shown) of inserter 10, the outer sheath 12and inner member 14 may instead be first and second portions of amonolithic structure, such that the first and second portions arerigidly fixed to each other. In such an embodiment, the outer sheath 12would be a first portion having a first diameter, and the inner member14 would be a second portion extending from the first portion and havinga second diameter. In one embodiment, the first diameter may be largerthan the second diameter such as to form a shoulder, similar to shoulder13, at the interface between the first and second portions. Thedifferences in these diameters may be such that when sleeve 20 is loadedonto the second portion, the outer surfaces of sleeve 20 aresubstantially tangent to the outer surfaces of the first portion. Inanother embodiment, the first and second diameters may be substantiallythe same.

In one embodiment of using such alternative monolithic inserter device,sleeve 20 may be loaded onto the second portion such that sleeve 20abuts the shoulder. A working filament, such as working filament 30, maybe grasped by the inserter, and then the inserter and sleeve 20 may beinserted into a bore hole in bone, as previously described with regardto inserter 10. However, unlike with inserter 10, the monolithicinserter may simply be pulled out of the bore hole once sleeve 20 isfully inserted into the bore hole. The second portion of inserter mayhave a highly polished outer surface such that the friction applied bythe inner surface of the bore hole against the outer surface of thesleeve 20 is greater than the friction applied to the inner surface ofthe sleeve 20 as the inserter 10 is removed, which may facilitate thebunching effect as previously described, and also allow the monolithicinserter to be removed without incidental removal of sleeve 20 from thebore hole.

FIGS. 10-12 depict another alternative embodiment of an inserter andmethod of use and/or method of assembly of an anchoring assemblycomprised of sleeve 320 and working filament 330. Similar to inserter10, inserter 310 includes an outer sheath 312 and inner member 314. Theinner member 314 also includes an actuation member 315 that includesfirst and second arms 317, 318 that are clampable together at theirrespective distal ends to form an opening 316 for retaining the workingfilament 330. However, unlike inserter 10, inserter 310 includes aneyelet 319 extending distally from the first or second arm member 317,318 and a loader 360 that can be passed through the eyelet 319.

The loader 360 may be a thread formed from filamentary material or wireformed from memory metal material, such as a nickel-titanium alloy, alsoknown as Nitinol, or the like. The loader 360 may have an elongate tail362 and looped head 364 disposed at the end of the elongate tail 362.The looped head 364 may have a diamond, ovular, or circular shape, forexample. An example of a Nitinol loader is disclosed in U.S. applicationSer. No. 14/104,480, filed on Dec. 12, 2013, the entirety of which ishereby incorporated by reference herein as if fully set forth herein.

In another embodiment of a method of use/assembly, the tail end of theloader 360 is passed into the eyelet 319 such that the tail 362 endextends from one side of the eyelet 319 and the head 364 end extendsfrom the other side of the eyelet 319. Sleeve 320 is then slid over theinner member 314 and over loader 360 such that the head 364 end and tail362 end extend from the first end 322 of sleeve 320 (best shown in FIG.10). It is noted that in an arthroscopic procedure, the elongate tail360 may have sufficient length to be manipulated by an operator outsideof the patient through a cannula while the inserter 310 is in use invivo. Just as with inserter 10, loading of sleeve 320 with inserter 310can be performed during the manufacturing process and delivered to theoperating room in a preloaded configuration or loaded in the operatingroom during or just prior to the procedure.

A working filament 330 that is coupled to the target tissue (not shown)may have a first and second free ends 332, 334 that may be passedthrough the opening 316 of the actuating member 315 and between the headend and tail end of the loader. The free ends 332, 334 of the workingfilament 330 may then be passed through the looped head 364, as shown inFIG. 10, which may be performed outside of the patient.

Thereafter, the distal end of inserter 310, with loader 360, sleeve 320,and working filament 330 engaged thereto, is inserted into a bore hole(not shown) formed in bone. Once the sleeve 320 is fully inserted intothe bore hole 320, a first loop configuration 336 is formed insubstantially the same manner as previously described with relation toinserter 10 by retracting the inner member 314 into the outer sheath312. However, unlike the first loop configuration 336 formed by inserter10, the elongate tail 362 of the loader 360 is positioned through thefirst loop configuration 336 once the first loop configuration 336 isformed.

With the actuating member 315 still in the first position with the firstand second arm members 317, 318 clamped together, the loader 360 istensioned such that the looped head 364 is drawn into the eyelet 319. Insome embodiments, the eyelet 319 may be large enough to allow the freeends 332, 334 to pass into the eyelet 319. In other embodiments, theeyelet 319 may be small enough to prohibit the free ends 332, 334 fromentering therein. In either embodiment, once the looped head 364 reachesthe eyelet 319, the actuating member 315 may be actuated such that thearms 317, 318 separate. Generally the eyelet 319 is positioned on thearm 317 or 318 disposed on the opposite side of the first loopconfiguration 336 as the free ends 332, 334. When the arms 317, 318separate the arm containing the eyelet 319 and looped head 364 begins topull the free ends 332, 334 through the first loop configuration 336.The inserter 310 may then be pulled away from the bore hole whichfurther pulls the free ends 332, 334 through the first loopconfiguration 336. The inserter 310 is continued to be pulled until theentirety of the free ends 332, 334 is passed through the first loopconfiguration 336 to form the second loop configuration 338, as depictedin FIG. 12.

Thereafter, the free ends 332, 334 may be tensioned to form the one-waycinch substantially in the same way as in the method utilizing inserter20. Inserter device 320 allows for the formation of the one-way cinchnear the bore hole, even during arthroscopic procedures, which mayfacilitate the use of a relatively short working filament as compared toworking filament 30 utilized with inserter 10.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. (canceled)
 2. A suture anchor insertion assembly, comprising: aninserter having a proximal end, a distal end, and a length extendingtherebetween, the distal end having an aperture surrounded by aperimeter of the aperture, the perimeter of the aperture including afirst portion and a second portion of the inserter, the first and secondportions being separable from each other such that in a secondconfiguration, a distance between the first and second portions isfurther than in a first configuration so that a gap is formed betweenthe first and second portions in the second configuration allowing afilament captured within the aperture to be released from the aperturethrough the gap; and a bone anchor having a length extending betweenfirst and a second ends thereof and an opening extending along thelength, the bone anchor being disposed over a portion of the length ofthe inserter such that the distal end of the inserter extends from afirst end of the bone anchor.
 3. The assembly of claim 2, wherein thefirst and second portions are curved towards each other such that, inthe first position, respective distal ends of the first and secondportions face each other.
 4. The assembly of claim 3, wherein, the inthe second position, the distal ends of the first and second portionsare positioned further apart from each other than in the first positionsuch that the gap is formed between the distal ends.
 5. The assembly ofclaim 2, wherein the bone anchor is a filamentary sleeve.
 6. Theassembly of claim 2, wherein the inserter includes an elongate shaft andthe bone anchor is positioned over the elongate shaft such that theelongate shaft extends through the opening of the bone anchor.
 7. Theassembly of claim 6, wherein the first and second portions extend froman end of the elongate shaft.
 8. The assembly of claim 2, wherein thefirst and second portions are adapted to pass through the opening of thebone anchor.
 9. A suture anchor insertion assembly comprising: aninserter having a proximal end, a distal end, and a length extendingtherebetween, the distal end having first and second members extendingtherefrom, the first and second members defining a perimeter of anaperture that extends between the first and second members, the firstand second members having a first configuration in which the first andsecond members form a closed perimeter about the aperture so as tocapture a filament within the perimeter, and a second configuration inwhich the first and second members form an open perimeter about theaperture so as to allow the filament to escape through a gap formed inthe open perimeter; and a bone anchor having a length extending betweenfirst and a second ends thereof and an opening extending along thelength of the bone anchor, the inserter extending through the opening ofthe bone anchor so that the first and second members are positionedcloser to the first end of the bone anchor than the second end thereof.10. The assembly of claim 9, wherein, in the first configuration, thefirst and second members are continuous with each other, and in thesecond configuration, the first and second members are discontinuouswith each other via the gap.
 11. The assembly of claim 9, wherein, inthe first configuration, distal ends of the first and second memberscontact each other, and in the second configuration, the distal ends ofthe first and second members do not contact each other.
 12. The assemblyof claim 9, wherein the bone anchor is a filamentary sleeve.
 13. Theassembly of claim 9, wherein the inserter includes an elongate shaft andthe bone anchor is positioned over the elongate shaft such that theelongate shaft extends through the opening of the bone anchor.
 14. Theassembly of claim 13, wherein the first and second members extend froman end of the elongate shaft.
 15. The assembly of claim 9, wherein thefirst and second members are adapted to pass through the opening of thebone anchor.
 16. A method of anchoring soft tissue to bone comprising:capturing a length of filament connected to soft tissue with a distalend of an inserter such that the length of filament extends through anaperture defined by the inserter; inserting the distal end of theinserter into a bone hole in a bone such that the aperture and a boneanchor positioned over a portion of a length of the inserter arepositioned within the bone hole; releasing the filament through a gapformed in the distal end of the inserter adjacent to the aperture; anddrawing the distal end of the inserter through the bone anchor from afirst end to a second end thereof while the bone anchor remainspositioned within the bone hole.
 17. The method of claim 16, wherein thedrawing step is performed before the releasing step so that a portion ofthe length of filament is positioned in the opening of the bone anchor.18. The method of claim 16, wherein the drawings step includes moving aninner member relative to an outer sheath positioned over the innermember, the bone anchor being positioned over the inner member.
 19. Themethod of claim 16, wherein the perimeter of the aperture includes afirst portion of the perimeter and a second portion of the perimeter,wherein the gap is formed by the first and second portions of theaperture separating from one another.
 20. The method of claim 16,forming the gap between first and second members of the distal end ofthe inserter, the first and second members defining a perimeter of theaperture.